After drugmaker GlaxoSmithKline petitioned the FDA Monday to bar dissolvable tobacco products from the market “until their sponsors can demonstrate to FDA that their marketing is appropriate for the protection of public health,” dissolvable tobacco lozenge maker Star Scientific is fighting back by asking the FDA permission to market their product as a lower-risk alternative to smoking. According to Star Scientific President Paul Perito, “Why shouldn’t tobacco users… have an opportunity to know this and make an informed decision? That’s why we took the risk, that’s why we spent the money.”
The tablets – Ariva and Stonewall — dissolve in the user’s mouth and contain roughly 1.5 and 4 milligrams of nicotine respectively. Even though Star Scientific says its method of tobacco cultivation and preparation produces tobacco leaves with lower carcinogenic concentrations, they can’t explicitly market their products as less risky than cigarettes.
But based on the report “Harm Reduction in Nicotine Addiction” by the Royal College of Physicians, smokeless tobacco products — like Star Scientific’s nicotine-delivery lozenges — are about 90 percent less harmful than cigarettes.
“I’m glad to see that this report made it into the article reporting on this issue, but there are many other harm reduction reports — our own included — that indicate non-combustible tobacco products are actually 99 percent less harmful than smoking cigarettes,” says ACSH's Dr. Gilbert Ross.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, is not opposed to Star Scientific’s recent application to the FDA. “If there are tobacco products out there that can be marketed in such a way that can significantly reduce the risk of disease, I don’t know of anybody who opposes that.”
Dr. Ross retorted, “I’ll believe that when I see it. Matt Myers and his organization have been among the most vehement opponents of harm reduction for addicted smokers.”
The take home message? “Dissolvable tobacco products such as those marketed by Star Scientific are among those non-combustible products that have the potential to help addicted cigarette smokers quit and start using something one-to-two orders of magnitude safer,” says Dr. Ross.